Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial
BackgroundPreterm-associated complications remain the main cause of neonatal death. Survivors face the challenges of short- and long-term complications. Among all complications, bronchopulmonary dysplasia (BPD) remains the first important cause of neonatal mortality and morbidity. Current treatment...
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2022.884366/full |
| _version_ | 1811205154243870720 |
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| author | Ren Zhuxiao Huang Ruoyu Yang Liling Ren Xuejun Yang Chunhui Ruan Wanfen Chen Zhifeng Dai Yiheng Zhang Qi Wei Wei Liu Zhipeng Pei Jingjun Yin Qigai Yang Jie Yang Jie |
| author_facet | Ren Zhuxiao Huang Ruoyu Yang Liling Ren Xuejun Yang Chunhui Ruan Wanfen Chen Zhifeng Dai Yiheng Zhang Qi Wei Wei Liu Zhipeng Pei Jingjun Yin Qigai Yang Jie Yang Jie |
| author_sort | Ren Zhuxiao |
| collection | DOAJ |
| description | BackgroundPreterm-associated complications remain the main cause of neonatal death. Survivors face the challenges of short- and long-term complications. Among all complications, bronchopulmonary dysplasia (BPD) remains the first important cause of neonatal mortality and morbidity. Current treatment does not address this main preterm complication. Cord blood is regarded as a convenient source of stem cells. The paracrine bioactive factors of stem cells contribute to tissue repair and immune modulation. Our clinical studies and those of others have shown that cord blood cell infusion is both safe and possibly effective in the prevention and treatment of BPD. The therapeutic use of cord blood has emerged as a promising therapy. However, the genetic heterogeneity between control and intervention groups may reduce the comparability especially among small sample trials. The purpose of this study protocol is to investigate the effects of autologous cord blood mononuclear cell (ACBMNC) infusion on the prevention of BPD in very preterm monozygotic twins of less than 32 gestation weeks.MethodsIn this prospective, randomized, placebo-controlled, double-blinded multicenter clinical trial, 60 pairs of monozygotic twin preterm neonates of less than 32 weeks admitted to the Neonatal Intensive Care Unit are randomly assigned to receive intravenous ACBMNC infusion (targeted at 5 × 107 cells/kg) or placebo (normal saline) within 24 h after birth in a 1:1 ratio. The primary outcome will be survival without BPD at 36 weeks of postmenstrual age. The secondary outcomes will include the mortality rate, BPD severity, other common preterm complication rates, respiratory support duration, length and cost of hospitalization, and long-term respiratory and neurodevelopmental outcomes during a 2-year follow-up. Furthermore, we will perform single-cell RNA sequencing for cord blood cells and blood cells 3–10 days after intervention and detect whether reactive oxygen species and inflammatory cytokines are present.ConclusionThis will be the first randomized, placebo-controlled, double-blinded trial to evaluate the efficacy of ACBMNC infusion to prevent BPD in monozygotic twin premature infants and investigate the underlying protective mechanisms. The results of this trial will provide valuable clinical evidence for translational application of cord blood cell therapy in very preterm infants.Trial registration: ClinicalTrials.gov, NCT05087498, registered 10/09/2021, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000BAD7&selectaction=Edit&uid=U0002PLA&ts=2&cx=qvyylv. |
| first_indexed | 2024-04-12T03:25:51Z |
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| institution | Directory Open Access Journal |
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| language | English |
| last_indexed | 2024-04-12T03:25:51Z |
| publishDate | 2022-12-01 |
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| series | Frontiers in Pediatrics |
| spelling | doaj.art-30d1f7d0ef644764af907643a9b2597c2022-12-22T03:49:42ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602022-12-011010.3389/fped.2022.884366884366Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trialRen Zhuxiao0Huang Ruoyu1Yang Liling2Ren Xuejun3Yang Chunhui4Ruan Wanfen5Chen Zhifeng6Dai Yiheng7Zhang Qi8Wei Wei9Liu Zhipeng10Pei Jingjun11Yin Qigai12Yang Jie13Yang Jie14Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, ChinaDepartment of Neonatology, The First Affiliated Hospital of Kangda College of Nanjing Medical University, Nanjing, ChinaDepartment of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, ChinaDepartment of Neonatology, Dongguan Maternal & Child Health Hospital, Dongguan, ChinaDepartment of Neonatology, Zhongshan Boai Hospital, Zhongshan, ChinaDepartment of Neonatology, Shunde Hospital, Southern Medical University, Foshan, ChinaDepartment of Neonatology, Dongguan Hospital, Southern Medical University, Dongguan, ChinaDepartment of Neonatology, Affiliated Maternal & Child Health Hospital of Foshan, South Medical University, Foshan, ChinaDepartment of Clinic Genetic Center, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, ChinaGuangdong Cord Blood Bank/Guangzhou Municipality Tianhe Nuoya Bio-Engineering Co. Ltd, Guangzhou, ChinaGuangdong Cord Blood Bank/Guangzhou Municipality Tianhe Nuoya Bio-Engineering Co. Ltd, Guangzhou, China0Department of Neonatology, Nanfang Hospital, Southern Medical University, Guangzhou, ChinaDepartment of Neonatology, The First Affiliated Hospital of Kangda College of Nanjing Medical University, Nanjing, ChinaDepartment of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, China0Department of Neonatology, Nanfang Hospital, Southern Medical University, Guangzhou, ChinaBackgroundPreterm-associated complications remain the main cause of neonatal death. Survivors face the challenges of short- and long-term complications. Among all complications, bronchopulmonary dysplasia (BPD) remains the first important cause of neonatal mortality and morbidity. Current treatment does not address this main preterm complication. Cord blood is regarded as a convenient source of stem cells. The paracrine bioactive factors of stem cells contribute to tissue repair and immune modulation. Our clinical studies and those of others have shown that cord blood cell infusion is both safe and possibly effective in the prevention and treatment of BPD. The therapeutic use of cord blood has emerged as a promising therapy. However, the genetic heterogeneity between control and intervention groups may reduce the comparability especially among small sample trials. The purpose of this study protocol is to investigate the effects of autologous cord blood mononuclear cell (ACBMNC) infusion on the prevention of BPD in very preterm monozygotic twins of less than 32 gestation weeks.MethodsIn this prospective, randomized, placebo-controlled, double-blinded multicenter clinical trial, 60 pairs of monozygotic twin preterm neonates of less than 32 weeks admitted to the Neonatal Intensive Care Unit are randomly assigned to receive intravenous ACBMNC infusion (targeted at 5 × 107 cells/kg) or placebo (normal saline) within 24 h after birth in a 1:1 ratio. The primary outcome will be survival without BPD at 36 weeks of postmenstrual age. The secondary outcomes will include the mortality rate, BPD severity, other common preterm complication rates, respiratory support duration, length and cost of hospitalization, and long-term respiratory and neurodevelopmental outcomes during a 2-year follow-up. Furthermore, we will perform single-cell RNA sequencing for cord blood cells and blood cells 3–10 days after intervention and detect whether reactive oxygen species and inflammatory cytokines are present.ConclusionThis will be the first randomized, placebo-controlled, double-blinded trial to evaluate the efficacy of ACBMNC infusion to prevent BPD in monozygotic twin premature infants and investigate the underlying protective mechanisms. The results of this trial will provide valuable clinical evidence for translational application of cord blood cell therapy in very preterm infants.Trial registration: ClinicalTrials.gov, NCT05087498, registered 10/09/2021, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000BAD7&selectaction=Edit&uid=U0002PLA&ts=2&cx=qvyylv.https://www.frontiersin.org/articles/10.3389/fped.2022.884366/fullcord blood mononuclear cellsbronchopulmonary dysplasiavery preterm monozygotic twinspreventionautologousstudy protocol |
| spellingShingle | Ren Zhuxiao Huang Ruoyu Yang Liling Ren Xuejun Yang Chunhui Ruan Wanfen Chen Zhifeng Dai Yiheng Zhang Qi Wei Wei Liu Zhipeng Pei Jingjun Yin Qigai Yang Jie Yang Jie Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial Frontiers in Pediatrics cord blood mononuclear cells bronchopulmonary dysplasia very preterm monozygotic twins prevention autologous study protocol |
| title | Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial |
| title_full | Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial |
| title_fullStr | Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial |
| title_full_unstemmed | Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial |
| title_short | Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial |
| title_sort | autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins a study protocol for a randomized placebo controlled double blinded multicenter trial |
| topic | cord blood mononuclear cells bronchopulmonary dysplasia very preterm monozygotic twins prevention autologous study protocol |
| url | https://www.frontiersin.org/articles/10.3389/fped.2022.884366/full |
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